Back to resultsAllogeneic Mesenchymal Stromal Cells in Elderly Patients With Hip Fracture
Primary Purpose
Femoral Neck Fracture
Status
Withdrawn
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
XCEL-MT-OSTEO-BETA
Surgical treatment
Sponsored by
About this trial
This is an interventional treatment trial for Femoral Neck Fracture focused on measuring mesenchymal stromal cells, stem cells, elderly, allogeneic, bone marrow, bone regeneration, fracture
Eligibility Criteria
Inclusion Criteria:
- Patient between70 and 85 years old
- Proximal femur fracture type 31A3 31a2 classification AO/ASIF.
- Deambulation prior to fracture.
- Written informed consent of the patient or family members.
Exclusion Criteria:
- Presence of implants at proximal femur level.
- Presence of local or systemic septic process.
- Septic arthritis.
- Dementia of any type.
- Hematological and biochemical analysis with significant alterations that contraindicate surgery.
- Patients with positive serology for HIV 1 and 2, Hepatitis B, Hepatitis C and syphilis.
- Neoplastic disease detected in the last five years or without complete remission.
- Immunosuppressive status.
- Patients who received corticosteroids in the 3 months prior to study initiation.
- Simultaneous participation in another clinical trial or treatment with another investigational product within 3 months prior to inclusion in the study.
- Other conditions or circumstances that may compromise the patient's participation in the study according to medical criteria.
- Patient refusal to be followed by a period that may exceed the clinical trial itself.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
XCEL-MT-OSTEO-BETA
Standard treatment
Arm Description
Adult ex-vivo expanded mesenchymal stromal cells from allogeneic bone marrow, cryopreserved, to combine with fibrin glue and cancellous human bone tissue + endomedullary nailing
Standard surgical treatment with isolated endomedullary nailing
Outcomes
Primary Outcome Measures
safety of XCEL-MT-OSTEO-BETA in proximal femur fractures by Adverse events, physical exam, laboratory tests.
Adverse events, physical exam, laboratory tests.
Secondary Outcome Measures
efficacy through CT scan
assessment of consolidation by determination of Hounsfield units in CT scan
efficacy through xRay
assessment of bone callus characteristics by standard radiology
efficacy by clinical assessment
Clinical assessment by visual analogue scale for pain
efficacy by quality of life questionnaire
EUROQoL-5D quality of life questionnaire
Full Information
NCT ID
NCT02630836
First Posted
December 10, 2015
Last Updated
March 16, 2017
Sponsor
Banc de Sang i Teixits
Collaborators
Fundacion Clinic per a la Recerca Biomédica
1. Study Identification
Unique Protocol Identification Number
NCT02630836
Brief Title
Allogeneic Mesenchymal Stromal Cells in Elderly Patients With Hip Fracture
Official Title
A Pilot Clinical Trial of ex Vivo Expanded Allogenic Adult Stem Cells Combined With Allogenic Human Bone Tissue (XCEL-MT-OSTEO-BETA) in Proximal Femur Fractures in Elderly Patients
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Withdrawn
Study Start Date
December 2015 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Banc de Sang i Teixits
Collaborators
Fundacion Clinic per a la Recerca Biomédica
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Prospective, unicenter, randomized, open-label, single-dose, two-arms blinded assessor pilot study. Thirty-two (32) elderly patients with hip fracture will be randomized to one of the two treatment-arms (Xcel-MT-osteo-beta or Standard treatment) and be followed for 12 month with the primary objective of safety. Secondary objectives are efficacy through axial tomography and xRay, clinical efficacy and quality of life questionnaire.
Detailed Description
Prospective, unicenter, randomized, open-label, single-dose, two-arms blinded assessor phase I-II pilot study.
Thirty-two (32) elderly patients (70-85 years of age) with type 31A2 y 31A3 fracture of the femur (AO/ASIF (Association for the Study of Internal Fixation) classification) admitted at the emergency room of the Hospital Clinic of Barcelona will be randomized 1:1 to one of the two treatment-arms (endomedullary nailing + XCEL-MT-OSTEO-BETA or isolated endomedullary nailing as the standard treatment). Once surgically treated, patients will be followed for 12 month with the primary objective of safety. Secondary objectives are efficacy through axial tomography and xRay, clinical efficacy and quality of life questionnaire (EUROQOL-5D).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Femoral Neck Fracture
Keywords
mesenchymal stromal cells, stem cells, elderly, allogeneic, bone marrow, bone regeneration, fracture
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
XCEL-MT-OSTEO-BETA
Arm Type
Experimental
Arm Description
Adult ex-vivo expanded mesenchymal stromal cells from allogeneic bone marrow, cryopreserved, to combine with fibrin glue and cancellous human bone tissue + endomedullary nailing
Arm Title
Standard treatment
Arm Type
Other
Arm Description
Standard surgical treatment with isolated endomedullary nailing
Intervention Type
Drug
Intervention Name(s)
XCEL-MT-OSTEO-BETA
Intervention Description
XCEL-MT-OSTEO-BETA followed by endomedullary nailing
Intervention Type
Procedure
Intervention Name(s)
Surgical treatment
Intervention Description
Isolated endomedullary nailing
Primary Outcome Measure Information:
Title
safety of XCEL-MT-OSTEO-BETA in proximal femur fractures by Adverse events, physical exam, laboratory tests.
Description
Adverse events, physical exam, laboratory tests.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
efficacy through CT scan
Description
assessment of consolidation by determination of Hounsfield units in CT scan
Time Frame
3 months
Title
efficacy through xRay
Description
assessment of bone callus characteristics by standard radiology
Time Frame
1, 3 and 6 months
Title
efficacy by clinical assessment
Description
Clinical assessment by visual analogue scale for pain
Time Frame
1, 3 and 6 month
Title
efficacy by quality of life questionnaire
Description
EUROQoL-5D quality of life questionnaire
Time Frame
3, 6 and 12 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
70 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient between70 and 85 years old
Proximal femur fracture type 31A3 31a2 classification AO/ASIF.
Deambulation prior to fracture.
Written informed consent of the patient or family members.
Exclusion Criteria:
Presence of implants at proximal femur level.
Presence of local or systemic septic process.
Septic arthritis.
Dementia of any type.
Hematological and biochemical analysis with significant alterations that contraindicate surgery.
Patients with positive serology for HIV 1 and 2, Hepatitis B, Hepatitis C and syphilis.
Neoplastic disease detected in the last five years or without complete remission.
Immunosuppressive status.
Patients who received corticosteroids in the 3 months prior to study initiation.
Simultaneous participation in another clinical trial or treatment with another investigational product within 3 months prior to inclusion in the study.
Other conditions or circumstances that may compromise the patient's participation in the study according to medical criteria.
Patient refusal to be followed by a period that may exceed the clinical trial itself.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Josep Maria Segur, MD, PhD
Organizational Affiliation
Hospital Clinic of Barcelona
Official's Role
Principal Investigator
12. IPD Sharing Statement
Links:
URL
http://bancsang.net
Description
Blood and Tissue Banc of Catalonia
URL
http://hospitalclinic.org
Description
Hospital Clínic de Barcelona
URL
http://fundacioclinic.org
Description
Hospital Clinic Foundation
Learn more about this trial
Allogeneic Mesenchymal Stromal Cells in Elderly Patients With Hip Fracture
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